A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT01572948
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • roflumilast — DRUG
    The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
  • placebo — DRUG
    The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient

Study Details

The purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD. The investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.

Key Dates

Start date
Jun 30, 2012
Status verified
Sep 2015
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.
  • Active Comparator: Daliresp
    The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models

Primary Outcome Measure

Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline [ Time Frame: baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
UAB Lung Health CenterBirminghamAlabama35294-

Find similar trials in Birmingham, AL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
UAB Lung Health Center· Birmingham, AL

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